We are seeking a highly skilled and experienced QC Microbiology Specialist to join our team in Social Circle, GA. This is a contract position with the potential to last up to six months. In this role, you will be a key player in our Quality Control department, leading critical microbiology and environmental monitoring activities. The ideal candidate will have extensive experience in a GMP-regulated environment and a proven track record of leading projects, managing quality systems, and ensuring compliance.
location: Social Circle, Georgia
job type: Contract
salary: $60 - 74 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Microbiology Testing & Method Lifecycle
- Perform and oversee GMP microbiological testing for raw materials, intermediates, and finished products.
- Lead method development, validation, and transfer activities in compliance with compendial and regulatory standards.
- Manage trending and analysis of assay controls and invalid assay results to identify patterns and drive continuous improvement.
- Environmental Monitoring & Data Trending
- Implement and maintain environmental monitoring programs for cleanrooms and controlled areas.
- Perform statistical analysis of monitoring data using Minitab or similar tools to assess state of control.
- Quality Systems & Compliance
- Lead and manage change control activities impacting QC processes and analytical methods.
- Conduct and document laboratory investigations in TrackWise; develop and implement CAPAs.
- Ensure alignment with USP, EP, and applicable regulatory agency guidelines.
- Equipment & Technology Management
- Oversee qualification and onboarding of analytical equipment for microbiology and analytical testing.
- Utilize and maintain electronic laboratory systems such as MODA and LabWare LIMS.
- Project & Documentation Management
- Lead cross-functional QC projects, including continuous improvement initiatives and technology upgrades.
- Author and review technical documents, including protocols, SOPs, final reports, and data summaries.
- Present data and recommendations to management and regulatory inspectors as needed.
qualifications:
Required
- Bachelors degree in scientific discipline
- 3-5 years of GMP experience performing QC microbiological testing (environmental monitoring, bioburden, endotoxin, utility monitoring, product testing)
- Experience with analytical method development and method validation
- Exposure to data and statistical analysis
- Experience with MODA, Labware LIMS, Excel, Python
- Change Control Management
- Equipment installation and qualification
- Chemistry knowledge
skills: Microbiology, Corrective and Preventive Actions (CAPA), Quality Control (QC)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
